The ENCIRCLE Trial

Eligibility Criteria

• 1. 18 years of age or older
• 2. MR ≥ 3+
• 3. NYHA functional class ≥ II
• 4. Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations.
• 5. Subject's heart failure management has been optimized based on subject characteristics and applicable guidelines, and stable for at least 30 days prior to enrollment.
• 6. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
• 1. Mitral/cardiac anatomy that would preclude appropriate delivery and deployment of the SAPIEN M3 dock or valve
• 2. Inappropriate anatomy for femoral introduction and delivery of the SAPIEN M3 dock and valve
• 3. Presence of any device that will contact or interfere with the SAPIEN M3 System during delivery or after implantation
• 4. Left ventricular ejection fraction \<25%
• 5. Severe right ventricular dysfunction
• 6. Need for aortic, tricuspid or pulmonic valve intervention within the next 12 months
• 7. History of heart transplant
• 8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
• 9. Active bacterial endocarditis within 180 days of the procedure
• 10. Hemodynamic instability requiring inotropic or mechanical support within 30 days of the procedure
• 11. Myocardial infarction within 30 days of the procedure
• 12. Clinically significant untreated coronary artery disease requiring revascularization
• 13. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the procedure
• 14. Stroke or transient ischemic attack within 90 days of the procedure
• 15. Irreversible, severe pulmonary hypertension
• 16. Chronic obstructive pulmonary disease requiring home oxygen therapy or chronic outpatient oral steroid use
• 17. Renal insufficiency or receiving renal replacement therapy
• 18. Liver disease
• 19. Planned surgery within the next 12 months
• 20. Inability to tolerate or a medical condition precluding treatment with antithrombotic therapy, including heparin administration during the procedure
• 21. Active infection requiring current antibiotic therapy
• 22. Active SARS-CoV-2 infection (Coronavirus-19 \[COVID-19\]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
• 23. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
• 24. Refusal of blood products
• 25. Female who is pregnant or lactating
• 26. Estimated life expectancy \<12 months due to non-cardiac conditions
• 27. Participating in another investigational drug or device study that has not reached its primary endpoint
• 28. Subject considered to be part of a vulnerable population